In the Netherlands, consideration regarding the surveillance of adverse drug reactions developed at a relatively early stage.
Pharmacovigilance in
the Netherlands
HISTORY AND ORGANIZATION
In
the Netherlands, consideration regarding the surveillance of adverse drug
reactions developed at a relatively early stage. In the early 1950s, at a time
when international literature had included only inci-dental reports of ‘side
effects’, Leo Meyler laid the basis for paying more systematic attention to
adverse drug reactions. In 1951, he published his book in Dutch: Schadelijke nevenwerkingen van
geneesmidde-len (literally: Harmful
Effects of Prescription Drugs). The
second edition, fully revised with a number of supplements, appeared in 1954.
In
his preface to the first edition, Meyler wrote the following (here in
translation):
The prescribing of
drugs will always entail a greater or lesser degree of risk, and in each case
the physician must ask himself whether the nature of the condition about which
he is being consulted justifies taking such a risk.
Meyler’s
work was prompted by his own experiences with tuberculostatic preparations. He
also warned against the inappropriate use of drugs.
Meyler
based much of his work on reports in various medical journals, at a time when
the Internet or other conveniences of modern times were non-existent. The first
English edition of Meyler’s seminal work was published in 1952 as The Side Effects of Drugs: An Encyclopaedia of Reactions and Interactions.
Its fourteenth edition, edited by Graham Dukes,
appeared in 2000. Dukes has been the editor since the eighth edition, published
in 1978, of what now has become the standard reference work in its field.
Dukes’ own scientific background was largely gained in the Netherlands.
Following
the thalidomide affair of the late 1950s and early 1960s, the Netherlands
decided to adopt a more systematic approach to the safety of prescription
medicines. The Dutch Medicines Evaluation Board was founded in 1963. Based on
the American model of the Food and Drug Administration, this board would assess
new pharmaceutical preparations for both effectiveness and safety prior to
marketing autho-rization. Also in 1963, the Royal Dutch Medical Association
(KNMG) joined the government in setting up a reporting system for adverse drug
reactions. In 1965, the task of processing reports was taken over by the
National Drug Monitoring Centre, which was part of the Public Health
Supervisory Service and came to acquire an extremely good reputation (Meyboom,
1996). With a relatively small staff, Lareb produced a significant number of
publications calling attention to the potential adverse effects of prescription
drugs (de Koning, 1994). Each year, the National Drug Monitor-ing Centre
received approximately 1000 reports from interested doctors.
In
1986, a number of pharmacists called for greater attention to be devoted to the
potential adverse effects of prescription medicines. These pharmacists were
convinced that greater awareness of the possibility of adverse effects would
improve the quality of phar-macotherapy as a whole. Their initiative led to the
creation of the Netherlands Pharmacovigilance Centre Lareb in 1991. A new
aspect was that pharmacists too felt their responsibility in the identification
of adverse effects and would consider it their task to call attention to such
effects (van Grootheest et al., 2002,
2003b).
In
1995, European legislation having been made more stringent, the Dutch
government decided to restructure the system of pharmacovigilance in the
Netherlands. Lareb was designated the national centre for all reports of
suspected adverse drug reactions concerning registered drugs. Currently, the
Health Inspectorate is responsible for monitoring the quality of
pharmacovigilance.
The
Medicines Evaluation Board plays a central coordinating role. It receives
reports from Lareb, as well as those made directly by the pharmaceu-tical
industry, and it advises the Medicines Evalua-tion Board. The Medicines
Evaluation Board makes the final decision regarding marketing authoriza-tion
for the Netherlands. Where deemed necessary it is empowered to require
amendments to a drug’s ‘Summary of Product Characteristics’ and in serious
cases may revoke a drug’s marketing authorization altogether. The Medicines
Evaluation Board includes a pharmacovigilance department primarily concerned
with adverse drug reactions and with maintaining international contacts in this
field. Many decisions are taken at European level by the European Medicines
Agency (EMEA).
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